1. Field of the Invention
This invention relates to an arterial device and method for control of bleeding from a puncture in an artery which is primarily for use in intensive therapy and interventional cardiology but which may have other medical or surgical application.
To gain access to an artery, the arterial wall must be penetrated. The opening in the arterial wall may initially be quite large, to enable the passage of for example a guiding catheter for transluminal coronary angioplasty or an intra-aortic balloon pump.
When the procedure requiring access to the artery has been completed, and the large diameter device can be removed, extensive bleeding has been found to occur at the puncture in the artery wall, particularly where, following cannulation with a large diameter device, a thin line needs to be left in place for hours or even days for further access in case of emergencies.
Removal of a large sized cannula therefore currently requires prolonged pressure with associated discomfort and often significant haemorrhage into the surrounding soft tissue. The degree of bruising and trauma is partly related to the size and partly to the duration for which the cannula has been left in situ.
Problems associated with arterial bleeding are highlighted in a review article in the Journal of Interventional Cardiology, Vol. 1, No. 2, 1994, pages 187-193--"Management of the Arterial Puncture Site" by Artur M. Spokojny, M.D. and Timothy A. Sanborn, M.D.
2. Description of the Prior Art
There are no arterial devices known to the applicant which assist the closure of a puncture in the wall of an artery to stem arterial bleeding. Arterial devices have been proposed for other purposes unrelated to the stemming of arterial bleeding by arterial wall puncture closure.
For example, U.S. Pat. No. 4,723,939 to Anaise deals with an arterial device for the complete closure of an arterial lumen in order to preserve organs of a cadaver prior to transplantation. The arterial device of Anaise has external band formations which are encircled and engaged by the arterial wall, completely occluding the bore. The device of Anaise is a cannula made of apparently rigid plastics material. It is sized so as to block the artery into which it is inserted.
U.S. Pat. No. 4,738,658 to Magro discloses a cannula device for stemming leakage bleeding from a catheter in situ in an artery. However the cannula device should not penetrate the blood vessel in normal use. It merely seals around the catheter. There is no teaching in Magro as to the control of bleeding from the arterial puncture left by removal of the catheter. This would need to be done by conventional methods such as manual pressing of the arterial puncture site over a prolonged period. Such external compression methods lead to the problems of discomfort, bruising and trauma at the puncture site which are outlined above.
As will be seen from the following description, I propose an arterial device comprising a tapering cannula for the purposes outlined above and for use in the method claimed. Tapering cannulae are known per se for other purposes, including catheterisation of the lung, for example illustrated by the "Thompson Bronchial Catheters" distributed by Bard.
However even the closest prior art known to me is not germane to my invention either as regards the arterial device I propose or the proposed method of use in controlling bleeding from an artery.